Denis Naughten (Longford-Roscommon, Fine Gael)
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Question 29: To ask the Minister for Agriculture and Food the status of the implementation of the animal medicines regulations; and if she will make a statement on the matter. [24579/06]

Mary Wallace (Meath, Fianna Fail)
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The Animal Remedies Regulations 2005, which are designed to transpose EU Directive 2004/28 as well as to amend certain provisions in our national legislation, came into effect on 17 November last. The EU directive provided, among other elements, that veterinary medicines for food-producing animals may only be supplied on the basis of a veterinary prescription unless exempted from this requirement under criteria to be drawn up at EU level before 1 January 2007.

However, the directive also included a provision permitting member states to retain existing national prescription arrangements pending a decision at EU level on the exemption criteria. My Department has decided to avail of this provision, which is reflected in the 2005 regulations. In light of this, all existing off-prescription medicines will remain off-prescription until the end of this year and farmers are continuing to get such medicines over the counter at pharmacies and licensed premises.

With regard to the exemption criteria, the European Commission began a public consultation phase on draft criteria last February. Our analysis of the draft criteria suggested they would place severe restrictions on the range of medicines which could remain off prescription. In view of this, my Department made a submission to the Commission last March setting out the disadvantages associated with its draft criteria and arguing in favour of a more flexible regime under which greater discretion would be given to member states in determining scientifically the appropriate route of supply for veterinary medicinal products based on the risk benefit profile of individual products.

Although the draft criteria were considered by experts from member states at the end of March, the Commission has not yet adopted the draft criteria as formal Commission proposals. When they are eventually formally adopted by the Commission, they will be subject to further consideration and vote at the regulatory committee in Brussels. My Department will continue to press its position and seek to have criteria adopted which give the maximum discretion to member states in determining whether individual veterinary medicines should become prescription only.

Additional information not given on the floor of the House.

During the negotiations on the regulations last autumn, the Minister gave a commitment to review the national distribution arrangements in consultation with stakeholders and in light of the outcome of the exemption criteria and, in particular, to consider whether persons other than vets should be permitted to prescribe veterinary medicines. In light of this, it is evident that, if the criteria are not altered significantly, my Department will revisit the prescribing aspects of the 2005 regulations.

Denis Naughten (Longford-Roscommon, Fine Gael)
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I raise this issue because farmers have told me they believe the bureaucracy and red tape in agriculture have gone too far, citing this regulation as evidence. As the proposals at European Commission level stand, wormers and medicines such as vaccines will require prescription as of 1 January 2007. Does the Minister have the support of other Ministers for the proposals she has put forward to the European Commission and the Council of Ministers? My understanding is that she has very little support. In case the Minister fails to overturn the Commission's current position on the introduction of prescription-only medicines, will she now put forward draft proposals on the implementation of new regulations to allow for people other than vets to write prescriptions?

Mary Wallace (Meath, Fianna Fail)
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All the issues are being considered. One area of concern was the expectation that the Commission would adopt the draft criteria proposals after the meeting at the end of March, but no formal decision was taken and we still await one. At the end of this year we can go in one of two directions, depending on the result of the Commission's deliberations. We will have to consider the Deputy's suggestion that people other than vets be allowed to prescribe items such as wormers in the context of the criteria the Commission sets, because the answer to his question hinges on them. If we are successful in our proposal that the position on wormers remain as it is today, the question will not arise. It will only arise if the criteria turn out to be as strict as the Commission currently proposes. We are fighting the case because we would prefer the status quo to remain.

Denis Naughten (Longford-Roscommon, Fine Gael)
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Is it not the case that the majority of the Minister's colleagues in Europe are opposed to the Irish position and that they want the position to be as proposed by the Commission? In light of that, is it not irresponsible of us not to have a plan B in place, with draft regulations and involving a consultation process during the summer months? If the Minister fails to convince the Commission on the Irish position, she can then quickly bring forward proposals and new regulations to ensure that not only vets but also licensed merchants and pharmacists can write prescriptions in certain circumstances, rather than waiting until the eleventh hour and failing to have them in place by 1 January 2007.

Mary Wallace (Meath, Fianna Fail)
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We have succeeded to the extent that, if we had not taken the stance we took, we would have had to designate the range of medicines as POMs 14 months earlier than at present. At least the status quo remains for the moment and will do so until the end of this year. If we had changed the regulations last year, we could have been accused of undermining our negotiating position with the Commission on the argument that the majority of existing non-POMs should remain off prescription, which is still our position.

Nothing has been lost by postponing our decision on the prescription issue and pursuing the exempted mechanism because existing off-prescription arrangements can remain in place in the interim, which is important. Following the result of the criteria debate in Brussels, we will work on what is decided.